ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614001264673

Ethics application status

Approved

Date submitted

25/08/2008

Date registered

3/12/2014

Date last updated

3/12/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Changing the home environment to support healthy physical activity and dietary patterns for children: a random controlled trial.

Scientific title

Comparison of home-based lifestyle support intervention strategies for obese children aged 4-11 years, relative to usual paediatric care as a means of improving physical activity and dietary patterns.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Home visits by trained professionals (3 visits; at baseline, 2 weeks and 4 months all of approximately the same duration ie 1-1.25 hour) to assess obeseogenicity of the home environment, provision of a written report for parents and ongoing support for the family to make lifestyle changes. By ongoing support we mean provision of evidence based practical strategies for improving healthy eating and physical activity in families. Particular emphasis was in provision of advice in non-judgemental supportive manner, sensitive to socio-ecomomic determinants of obesity. This additional support was provided by phone-calls in between home visits 2-3. The total intervention time was 6 months.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

The control group was wait-listed (ie received the intervention 6 months after the initial intervention group). During the wait-list time period the child may have been seeing a paediatrician, GP or other health care professional for weight management (ie standard care).

Control group

Active

Outcomes

Primary outcome [1]

Child's dietary patterns using a validated instrument. Parents completed the 24-item Children’s Dietary Questionnaire (CDQ) which generates four continuous scores (i.e. fruit and vegetables, non-core foods, fat from dairy, sweetened beverages). Non-core foods are defined as foods that are not essential to meet nutrient requirements and contain excess energy, fat, sugar and salt. The CDQ shows acceptable reliability (ICC 0.5 to 0.9) and relative validity at the group level for the fruit and vegetables and non-core food scores (Cronbach alpha 0.62 to 0.72).

Timepoint [1]

6 months after the intervention commenced.

Primary outcome [2]

Child's physical activity patterns using a validated instrument. Child activity patterns were measured using an adapted version of The Outdoor Play and Small Screen Entertainment Checklist. Parents reported the average time children spent per weekday and weekend day (in hours and minutes) (i) playing outdoors, (ii) doing moderate-vigorous physical activity, and (iii) using electronic media such as television and computers for both. Six items were added to the original checklist to explore average time spent per day (iv) participating in physical activity and (v) using small screen entertainment. Times were averaged (weighted for type of day) to calculate (1) daily activity (vigorous physical activity + outdoor play) and (2) daily sedentary activity.

Timepoint [2]

6 months after the intervention commenced.

Secondary outcome [1]

Child's Body Mass Index (BMI) z score. child weight and height were measured to the nearest 0.1kg and 0.1cm, using standardised scales and stadiometer. BMI was calculated (weight, kg/height, m2) and weight status determined by applying the IOTF cut-points. BMI z-scores were calculated using LMSGrowth Excel add-in which is based on 1990 United Kingdom reference data.

Timepoint [1]

6 months after the intervention commenced

Eligibility

Key inclusion criteria

Children
BMI >95 percentile

Minimum age

4 Years

Maximum age

11 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children with a medical condition with potential to impact on growth
Children currently receiving another intervention program other than usual paediatric care

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealment by sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomization table created by a computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/06/2008

Date of last participant enrolment

Anticipated

Actual

7/08/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Channel 7 Children's Research Foundation

Address [1]

PO Box 2438, Regency Park, SA 5942

Country [1]

Australia

Primary sponsor type

University

Name

FLinders University

Address

1 Flinders Drive, Bedford Park, SA, 5042

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

1 Flinders Drive, Bedford Park, SA, 5042

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Clinical Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre, 1 Flinders Drive, Bedford Park, SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/01/2008

Ethics approval number [1]

136/07

Summary

Brief summary

This project is utilising a randomised controlled study to determine whether a novel home-based intervention focusing on altering the home environment results in short-term improvements in dietary, physical activity and sedentary behaviour patterns of children with obesity aged 4 -11 years. Eighty-four children, referred for management of obesity to Flinders Medical Centre (FMC), will be recruited over a two year period. Children will be randomised to receive a home-based lifestyle support intervention in addition to usual care by a paediatrician or to the control group (paediatrician care alone). Outcomes which will be assessed at six months after the intervention will include improvements in physical activity and dietary patterns of children. These outcomes will be assessed using both direct (accelerometer data) and indirect (questionnaire data) methods. The study hypothesis is that obese children enrolled in this study will have better dietary patterns, physical activity and sedentary behaviour patterns at 6 months from initial assessment compared to a control group of obese children receiving standard care

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Nicola Spurrier

Address

Department of Paediatrics and Child Health, Flinders University, 1 Flinders Drive, Bedford Park, SA 5042

Country

Australia

Phone

61 429567533

Fax

nicola.spurrier@flinders.edu.au

Contact person for public queries

Name

Liz Lowe

Address

Department of Paediatrics and Child Health, 1 Flinders Drive
Flinders Medical Centre, Bedford Park, SA 5042

Country

Australia

Phone

+61 8 8240 8917

Fax

elizabeth.lowe@health.sa.gov.au

Contact person for scientific queries

Name

Nicola Spurrier

Address

Department of Paediatrics and Child Health
Flinders Medical Centre, 1 Flinders Drive, Bedford Park, SA 5042

Country

Australia

Phone

+61 8 82044459

Fax

nicola.spurrier@flinders.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Minimal change in children's lifestyle behaviours and adiposity following a home-based obesity intervention: results from a pilot study.	2016	https://dx.doi.org/10.1186/s13104-015-1796-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically